Patient with advanced osteoarthritis and indication for endoprosthetic joint replacement of the knee joint (knee TEP)
Conditions
Interventions
Group 1: Group 1:
- Opti Track Athletic group: patients undergo the Fast Track program and Athletic treatment regimen during the clinical stay, with pre-rehabilitation and two-phase rehabilitation wit
Sponsors
Medizinische Hochschule Hannover
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: - Indication for primary implantation of a total knee joint endoprosthesis - Age: 18 - 80 years - Patient is gainfully employed
Exclusion criteria
Exclusion criteria: - ASA 3-6 - BMI > 34 kg/m2 - Diabetes mellitus with blood glucose imbalances (hypoglycemias) - Chronic renal insufficiency with GFR < 60 (stage III according to NKF) - Coronary artery disease with Z.n. intervention within the last 2 years or further complaints - Permanent anticoagulation with heart valve replacement - Dementia or other neurological diseases with alteration of gait (Parkinson's syndrome, myasthenia gravis, visual pathway disorders, etc.) - Anemia/hemophilia/thrombophilia with secondary DVT/LAE - Known depression/psychoaffective disorder - Chronic pain patient with long-term opioid medication/fibromyalgia - Rheumatoid arthritis with expected limitation in postoperative mobilization - COPD with limitations in daily living/sleep apnea syndrome - Massive ROM deficit - Lack of compliance for complex treatment procedures - Language barrier Subsequent exclusion from clinical trial: - Loss of assignment to OptiTrack Athletic group and continued treatment according to standard (time: until discharge).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of the Knee Injury and Osteoarthritis Score including Western Ontario and McMaster Universities Osteoarthritis Index (KOOS including WOMAC) score after 3 months, reflecting the functionality and quality of life of patients who underwent two different treatment regimens. We expect a superiority, in terms of postoperative outcome, of the Athletic group over the Classic group. The study will be considered successful if this superiority can be demonstrated. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Acquisition and comparison KOOS six, twelve and 24 months postoperatively - Acquisition of PROMS University of California Los Angeles Activity Score (UCLA), Oxford Knee Score (OKS), Knee Society Score (KSS), Forgotten Joint Score (FJS), European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L), Chronic Pain Grade according to von Korff ( CPG n. v. Korff), Depression Anxiety Stress Scales (DASS) - Assessment of pain via Visual Analog Scale (VAS) - Measurement of the knee joint extension force (M. quadriceps femoris) via dynamometer - Recording of postoperative complications - Recording of the readmission rate - Assessment of the effect of the two treatment regimens on obesity, diabetes mellitus type II, chronic pain syndrome - Assessment of the effects of the two treatment regimens on the time of complete reintegration into the profession or on the time of resumption of the profession or occupation, respectively. | — |
Countries
Germany
Contacts
Public ContactYvonne Noll
Orthopädische Klinik der Medizinischen Hochschule Hannover im Diakovere Annastift
Outcome results
None listed